{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-03518", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458093", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "brand_name": "DA VINCI S SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250827", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20130912", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "37 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345948", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3730161", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO SUSTAINED A SMALL LACERATION TO THE SIGMOID COLON DURING A DA VINCI S LEFT OOPHORECTOMY PROCEDURE ON (B)(6) 2011. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE RISKS AND BENEFITS OF THE SURGERY WERE EXPLAINED TO THE PATIENT. ACCORDING TO THE INFORMATION PROVIDED IN THE OP REPORT, DURING THE SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED SEVERE PELVIC ADHESIONS. REPORTEDLY, WHILE THE SURGEON WAS PERFORMING LYSIS OF ADHESIONS, A VERY SMALL LACERATION 1.5CM TO THE ANTIMESENTERIC BORDER OF THE SIGMOID COLON WITH MINIMAL SPILL OCCURRED. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. THE PATIENT UNDERWENT A COLORRHAPHY FOR REPAIR OF THE COLON. THE AFFECTED AREA WAS REPAIRED USING SILK SUTURES. THIS PROVIDED AN EXCELLENT CLOSURE AND NO COMPROMISE OF THE LUMEN. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED FROM THE OPERATING ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011." }, { "mdr_text_key": "11199806", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOUND NO DA VINCI PROCEDURE FOR THE REPORTED PROCEDURE DATE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED A LACERATION TO THE SIGMOID COLON BEFORE OR AFTER A PLANNED DA VINCI S LEFT OOPORECTOMY PROCEDURE." }, { "mdr_text_key": "32589270", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON MAY 7, 2014 INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE RISK MANAGER AT THE HOSPITAL WHERE THE PATIENT UNDERWENT THE ROBOTIC PROCEDURE. ACCORDING TO THE RISK MANAGER, THE PATIENT'S MEDICAL RECORDS WERE REVIEWED. THE RISK MANAGER INDICATED THAT THE PATIENT UNDERWENT A SALPINGO-OOPHORECTOMY PROCEDURE THAT STARTED OUT ROBOTICALLY; HOWEVER, THE PATIENT HAD SEVERAL BOWEL ADHESIONS AND DURING LYSIS OF THE ADHESIONS AN ENTEROTOMY OCCURRED. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY TO ALLOW FOR REPAIR OF THE ENTEROTOMY AND FOR COMPLETION OF THE SURGICAL PROCEDURE. THE RISK MANAGER INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND/OR AN OPERATIVE COMPLICATION THAT WAS THE RESULT OF THE DA VINCI SURGICAL SYSTEM. NO OTHER INFORMATION WAS PROVIDED. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL'S RISK MANAGER, IT HAS BEEN DETERMINED THAT THE INJURY SUSTAINED BY THE PATIENT WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES, AND WAS LIKELY DUE TO THE PATIENT'S BOWEL ADHESIONS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/05/2014" } ] }